Results from bench studies favor a new open-faced stone retrieval device (Dakota, Boston Scientific) for having greater versatility, efficacy, and durability compared with a competing product, and the in vitro performance of the new instrument is consistent with early clinical experience, said Roger L. Sur, MD, at the 2016 World Congress of Endourology in Cape Town, South Africa.
“In early clinical use in my hands, the Dakota basket has helped me to achieve my goal of rendering patients stone-free using a single basket. In particular, the Dakota has the ability to pick up even 1-mm stone fragments in patients, and that is something I have not seen with other baskets that are commercially available,” said Dr. Sur, director of the University of California, San Diego Comprehensive Kidney Stone Center, and an investigator in the bench studies.
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“Now, I look forward to see if my positive impressions are confirmed by findings from a user survey as well as by other urologists.”
The new nitinol hybrid grasper basket was released for limited market evaluation in August 2016 and fully in October 2016. It is available in two basket sizes—8 mm and 11 mm—and features a proprietary design (OpenSure Handle) that allows the basket to be opened larger (50% for the 8-mm device and 30% for the 11-mm device) when needed to accomplish stone release.
“This feature enables the release of larger stones, and really confers a huge safety benefit for patients,” Dr. Sur told Urology Times.
The bench studies compared the new basket with the NGage (Cook Medical). To investigate efficacy and versatility, 15 8-mm and 15 11-mm devices from each manufacturer were evaluated for their ability to retrieve and release simulated stone models through a simulated endoscopic 3.6F working channel. The performance of the 8-mm devices was assessed for stone models ranging in size from 1 mm to 9 mm, while stones up to 11 mm were used in the tests for the larger device. If a stone was not released when the basket was opened, the device handle was shaken. The “Sure Release” feature of the new device was used only if a stone was not disengaged by shaking.
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Results for the tests of the 8-mm baskets showed both products captured all stones up to 8 mm in size, but the Dakota demonstrated greater efficacy than the NGage for releasing stones measuring 7 mm and 8 mm. For 7-mm stones, the release rate after opening the basket was 100% for the Dakota device versus 13% for the NGage. After simple opening or shaking, all 15 Dakota devices released 8-mm stones, whereas stones of this size had to be manually removed from 13 (87%) of the NGage baskets.